RE: Manufacturing and supply agreement for enstend27 Aug 2024 04:50
Morning The.Italian.
Although it can be regarded as positive in a small way, I am disappointed that it has taken nigh on 5 months to sign an agreement which was agreed in March. ref my question to JG regarding the timing..
According to the chairman's statement an agreement was finalised by the end of 2023 yet we are now 6 months in and still no progress has been made, otherwise it would have been announced
You are correct, this is the wording that appeared in the Chairman’s statement but this is correct as at 27 March 2024 (and not 31 December 2023). “We are just waiting for Wanbang Biopharmaceutical, our commercial strategic partner for China, and the contract manufacturer to enter into the manufacturing and supply agreement as the agreement has now been finalised [as at 31 March 2024]. Once this has been done, the NDA will be submitted to the NMPA and we expect to receive marketing authorisation within 12 months provided that there are no deficiencies received from the NMPA. Once approved, the Group expects to receive US$5 million (before withholding tax) and US$2 million (before withholding tax) on commercialisation in China.”
What is interesting is this statement "Rest assured, we are pushing the parties as hard as we possibly can and of course we will update the market via the appropriate announcement". Yet they now appear to insinuate that it wasn't necessary to make the statement since is voluntary. ?
The point I am making is: Why has it taken 5 months just for a signature? We now have to wait god knows how many months for them to receive the data, since JG also states "but in any event no later than 3 months of receipt of the manufacturing information", however. Given it took 5 months just to sign an already agreed agreement, its bound to take just as long to receive the data and then another supposed 3 months to translate and include it in the submission. Given RPG's track record on constantly not achieving announced timelines, I will be very surprised if the submission is actually made before the end of the year. We then have to wait a year for approval and possible another year for them to commercialise the product (ref Haleon and Eroxon which is over a year so far).
We then, again, have the money problem as the current loan by JM runs out mid next year....what then ?
Also, I have this niggling feeling that a second amended agreement may have been made with Recordati since the original agreement (as much as we know) didn't mention OTC and given the price/can has dropped 60%, surely Recordati will want a larger %, which leads to the question: How are the projected sales, as included in the past presentations, impacted by these changes. There has been no further projections whatsoever after 2019 which provides inventors with information as to whether there is still a worthwhile market ?